A Multi-center, Randomized, Double-blind, Placebo Control Phase 1b/II Study to Evaluate the Safety and Efficacy of IMC-002 for the Treatment of Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of active SLE.

Start Date10 Oct 2024

Sponsor / Collaborator

ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.

CTR20231000

/ RecruitingPhase 1/2

注射用IMM0306联合来那度胺治疗复发/难治CD20阳性B细胞非霍奇金淋巴瘤的Ib/Ⅱa 期临床研究

[Translation] Phase Ib/Ⅱa clinical study of IMM0306 for injection combined with lenalidomide in the treatment of relapsed/refractory CD20-positive B-cell non-Hodgkin's lymphoma

Ib期：剂量递增阶段：评估IMM0306与来那度胺联合用药的安全性和耐受性，确定最大耐受剂量（MTD）（如有）和推荐2期剂量（RP2D）；初步评估IMM0306与来那度胺联合用药的抗肿瘤疗效；评估IMM0306与来那度胺联合用药的免疫原性；评估IMM0306与来那度胺联合用药的药代动力学（PK）特征；探索IMM0306的暴露与疗效、安全性的相关性（如数据允许）；探索生物标志物与安全性的相关性；探索淋巴细胞亚群变化与疗效相关性； IIa期：队列扩展阶段评估IMM0306与来那度胺联合用药的抗肿瘤疗效；进一步评估IMM0306与来那度胺联合用药的抗肿瘤疗效；进一步评估IMM0306与来那度胺联合用药的安全性和耐受性；注射用IMM0306与来那度胺联合用药在CD20阳性B-NHL受试者中的免疫原性；基于群体PK分析方法，表征IMM0306在晚期实体瘤受试者中的PK特征（如数据允许）；探索IMM0306的暴露与疗效、安全性之间的相关性（如数据允许）。

[Translation]

Phase Ib: Dose escalation phase: Evaluate the safety and tolerability of IMM0306 combined with lenalidomide, determine the maximum tolerated dose (MTD) (if any) and the recommended phase 2 dose (RP2D); preliminarily evaluate the anti-tumor efficacy of IMM0306 combined with lenalidomide; evaluate the immunogenicity of IMM0306 combined with lenalidomide; evaluate the pharmacokinetic (PK) characteristics of IMM0306 combined with lenalidomide; explore the correlation between IMM0306 exposure and efficacy and safety (if data permits); explore the correlation between biomarkers and safety; explore the correlation between changes in lymphocyte subsets and efficacy; Phase IIa: Cohort expansion phase To evaluate the anti-tumor efficacy of IMM0306 in combination with lenalidomide; to further evaluate the anti-tumor efficacy of IMM0306 in combination with lenalidomide; to further evaluate the safety and tolerability of IMM0306 in combination with lenalidomide; to evaluate the immunogenicity of IMM0306 for injection in combination with lenalidomide in subjects with CD20-positive B-NHL; to characterize the PK characteristics of IMM0306 in subjects with advanced solid tumors based on population PK analysis methods (if data permit); to explore the correlation between the exposure of IMM0306 and its efficacy and safety (if data permit).

Start Date07 Jun 2023

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.

NCT05771883

/ Not yet recruitingPhase 1/2

A Phase Ib/IIa Clinical Study of IMM0306 fo r Injection in Combination With Lenalidomide for the Treatment of Relapsed/Refractory CD20-Positive B-Cell Non-Hodgkin's Lymphoma Cell Non-Hodgkin's Lymphoma

The objective of this study was to evaluate the safety and efficacy of IMM0306 in combination with lenalidomide in patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.

Start Date01 May 2023

Sponsor / Collaborator

ImmuneOnco Biopharmaceuticals (Shanghai), Inc.

100 Clinical Results associated with Amulirafusp alfa

100 Translational Medicine associated with Amulirafusp alfa

100 Patents (Medical) associated with Amulirafusp alfa

Literatures (Medical) associated with Amulirafusp alfa

01 Mar 2023·Leukemia

IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, exerts excellent cancer killing efficacy by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcɣR engagement by simultaneously binding to CD47 and CD20 of B cells

Letter

Author: Liu, Dandan ; Zhang, Li ; Peng, Liang ; Yu, Jifeng ; Tian, Wenzhi ; Guo, Huiqin ; Song, Yongping ; Zhao, Gui ; Liu, Sijin ; Tu, Xiaoping ; Li, Song ; Chen, Dianze ; Zhang, Wei ; Bai, Xing ; Zhang, Ruliang ; Yang, Chunmei ; Jiang, Zhongxing

CD47, as the 'don't eat me' signal, interacts with the inhibitory signal-regulatory protein alpha (SIRPα) receptor expressed by myeloid cells and activated NK cells and is overexpressed in different malignancies, causing tumors to escape the phagocytosis of macrophages.Here, we describe the antitumor mechanism of IMM0306, a fusion protein of CD20 monoclonal antibody (mAb) with the CD47 binding domain of SIRPα , by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcγR engagement by simultaneously binding to CD47 and CD20 of B cells in different mouse xenograft tumor models.IMM0306 is a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα on both heavy chains, that was constructed and produced using an inhouse developed CHO-K1 cell expression system; whose binding activity was analyzed by flow cytometry.The phagocytosis and in vitro anti-tumor activity of IMM0306 were evaluated by antibody-dependent cellular phagocytosis (ADCP), antibody-dependent cell-mediated cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC) assays.The ADCC assay showed that IMM0306 has strong ADCC induced by activating NK cells through enhanced Fc/ FcγRRIIIa interaction.In conclusion, our data demonstrated that IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα , exerts excellent cancer killing efficacy by activating both macrophages and NK cells via blockade of CD47-SIRPα interaction and FcγR engagement by simultaneously binding to CD47 and CD20 of B cells.We conclude the mechanism of action of IMM0306 by blocking the CD47 'don't eat me' signal and activating the Fc-receptor 'eat me' signal of CD20 with a strong ADCP to make the B-cell fully killed, whereas CD47 mAbs and rituximab can only either block the CD47 'don't eat me' signal or activate the Fc-receptor 'eat me' signal of CD20 with limited ADCP to make the limited B-cell killed.The Fc segment of the recombinant protein in IMM0306 is IgG1 and has been modified by ADCC-enhanced genetic engineering.Therefore, it has strong in vivo efficacy (through ADCC and ADCP).For other CD47 BsAbs, because the CD47 antibody itself combines with red blood cells, IgG1 cannot be selected; otherwise, it will have severe anemia toxicity.Therefore, this data revealed that IMM0306 has a safer profile and superior therapeutic potential than other CD47 mAbs and BsAbs.

Journal of Hematology & Oncology

Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study

Article

Author: Shi, Yuankai ; Zhou, Keshu ; Song, Yongping ; Li, Zhiming ; Zhang, Mingzhi ; Wang, Zhen ; Yu, Li ; Meng, Wei ; Yang, Jianliang ; Jing, Hongmei ; Lu, Qiying ; Tian, Wenzhi

BACKGROUND:

Amulirafusp alfa (IMM0306) is a fusion protein of CD47 binding domain of signal-regulatory protein alpha (SIRPα) with CD20 monoclonal antibody on both heavy chains. This study aimed to evaluate the safety and preliminary efficacy of amulirafusp alfa in relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL).

METHODS:

We enrolled patients with CD20 + r/r B-NHL who had previously received at least two lines of therapy to receive a single-dose of amulirafusp alfa in the first 2 weeks, followed by a multiple-dose period, in which the patients received the same intravenous dose every week in 4-week cycles. The primary endpoints were to evaluate the safety, determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of amulirafusp alfa.

RESULTS:

Between May 22, 2020 and February 10, 2022, 48 patients with r/r B-NHL were enrolled and received amulirafusp alfa at the doses of 40-2000 μg/kg. As of the data cut-off date of April 18, 2024, no dose-limiting toxicity was observed, and the MTD was not reached. The dose of 2000 μg/kg was identified as the RP2D. All grades and ≥ grade 3 treatment-related adverse events (TRAEs) occurred in 48 (100%) and 33 (68.8%) patients, respectively. The most common ≥ grade 3 TRAEs were lymphocyte count decreased (28/48, 58.3%), white blood cell count decreased (10/48, 20.8%), absolute neutrophil count decreased (9/48, 18.8%) and anemia (5/48, 10.4%). At the doses of 800-2000 μg/kg, objective response rate in follicular lymphoma and marginal zone lymphoma was 41.2% (7/17, 95% confidence interval [CI] 18.4-67.1) and 33.3% (2/6, 95% CI 3.7-71.0), respectively.

CONCLUSION:

Amulirafusp alfa showed favorable safety profile and preliminary efficacy in patients with r/r B-NHL, meriting further investigation. Trial registration NCT05805943.

HAEMATOLOGICA

Lymphoma cell-driven IL-16 is expressed in activated B-cell-like diffuse large Bcell lymphomas and regulates the pro-tumor microenvironment

Article

Author: Hao, Mu ; Li, Ru ; Wang, Jingya ; Guan, Xuwen ; Qiu, Lugui ; Fang, Teng ; Wang, Yi

The activated B-cell–like subtype of diffuse large B-cell lymphoma (ABC-DLBCL) displays a worse outcome than the germinal center B-cell–like subtype (GCB-DLBCL). Currently, targeting tumor microenvironment (TME) is the promising approach to cure DLBCL with profound molecular heterogeneity, however, the factors affecting the tumor-promoting TME of ABCDLBCL are elusive. Here, cytokine interleukin-16 (IL-16) is expressed in tumor cells of ABCDLBCL and secreted by the cleavage of active caspase-3. The serum IL-16 levels are not only a sensitive marker of treatment response but also positively correlated with unfavorable prognosis in DLBCL patients. While IL-16 shows few direct promotional effects on tumor cell growth in vitro, its bioactive form significantly promotes tumor progression in vivo. Mechanically, IL-16 increases the infiltration of macrophages by the chemotaxis of CD4+ monocytes in the TME enhancing angiogenesis, and the expression of cytokine IL-6 and IL-10, as well as decreasing T cell infiltration to accelerate tumor progression. This study demonstrates that IL-16 exerts a novel role in coordinating the bidirectional interactions between tumor progression and the TME. IMM0306, a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα, reverses the tumorpromoting effects of IL-16,which provides new insight into treatment strategy in ABC-DLBCL.

News (Medical) associated with Amulirafusp alfa

24 May 2024

·www.prnewswire.com

Lunit to Showcase 7 Studies at ASCO 2024, including AI Innovations in HER2 Quantification, and Multimodal Predictive Models for Immunotherapy Response

- Lunit's ASCO 2024 presentations to highlight advances including HER2 ultra-low detection and AI-powered ICI response prediction models for NSCLC, demonstrating the impact of Lunit SCOPE suite on precision oncology SEOUL, South Korea, May 24, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the presentation of seven studies at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago, from May 31 to June 4. Lunit will present detailed findings on several innovative studies, including the identification of HER2 ultra-low expression in breast cancer using AI-based quantification, and a deep learning-based model integrating chest CT and histopathology analysis for predicting immunotherapy response in non-small cell lung cancer (NSCLC). Continue Reading Visit Lunit at booth IH22 to discover how the Lunit SCOPE suite is revolutionizing oncology research and clinical practice. In a poster presentation, Lunit's AI-powered HER2 analyzer, Lunit SCOPE HER2, demonstrated the ability to identify HER2 ultra-low expression and differentiate it from true HER2-negative cases in breast cancer patients using continuous subcellular quantification from HER2 immunohistochemistry (IHC) images. According to findings presented at ASCO 2022, HER2-targeted antibody-drug conjugates (ADCs) can effectively target tumor cells even in HER2-low breast cancers. This highlights the importance of accurately identifying HER2-low and HER2 ultra-low expression in breast cancer, especially for patients previously classified as HER2-negative. In response, Lunit developed an AI-based whole-slide image (WSI) analyzer for IHC-stained slides to differentiate between true HER2-negative and HER2 ultra-low cases. The AI model evaluated over 67 million tumor cells and 119 million non-tumor cells from 401 WSIs, identifying a significant proportion of HER2 ultra-low cases among pathologist-assessed HER2 score 0 cases. This AI-powered analysis could expand and refine treatment options for patients with HER2-targeted therapies, as demonstrated by the 23.6% of HER2 score 0 cases identified as HER2 ultra-low by AI, and the 51.9% of HER2 score 1+ cases classified as HER2 low by AI, comparable to the 52.3% objective response rate to a HER2-targeted ADC observed in another clinical trial. In another study, Lunit developed and validated an AI model that analyzes patients' chest CT images alone and in combination with pathology images to predict Immune Checkpoint Inhibitor (ICI) response in NSCLC patients. Lunit's deep learning-based chest CT prediction model, developed using data from 1,876 NSCLC patients treated with ICIs, predicted treatment response based on pre-treatment chest CT scans, along with PD-L1 status and immune phenotype. The model demonstrated significant predictive power as an independent biomarker. Patients predicted as responders by the AI model showed significantly longer median time to the next treatment (TTNT; 7 months vs. 2.5 months) and a longer overall survival (OS; 16.5 months vs. 7.6 months) compared to patients predicted as non-responders. Combining the AI CT model with histopathologic biomarkers such as PD-L1 expression and tumor-infiltrating lymphocytes (TILs) further enhanced prediction accuracy, highlighting the complementary strengths of imaging and pathology data in improving predictive models for ICI response. A collaborative study with Stanford University School of Medicine examined the association of immune phenotypes with outcomes after immunotherapy in metastatic melanoma, highlighting the heterogeneity of immune phenotypes across melanoma subtypes. Another study with Northwestern University utilized AI-powered analysis of tertiary lymphoid structures (TLS) in H&E whole-slide images to predict immunotherapy response in NSCLC patients. This demonstrated AI's potential in identifying predictive biomarkers for survival outcomes. "At ASCO 2024, Lunit proudly presents seven groundbreaking studies that illustrate our pioneering role in AI-driven precision oncology," said Brandon Suh, CEO of Lunit. "From HER2 quantification to predictive models for immunotherapy response, our work is transforming oncology by making cancer treatment not just personalized but predictive, ensuring the best possible outcomes for patients worldwide." In addition to the studies above, Lunit will present three more studies at this year's ASCO, demonstrating the diverse capabilities of the Lunit SCOPE suite. The studies include comprehensive histopathomic prediction models for early breast cancer, and hypothetical test-and-control group generation for treatment selection in TPS-high NSCLC. Visit Lunit at booth IH22 to discover how the Lunit SCOPE suite is revolutionizing oncology research and clinical practice. Presentations at ASCO 2024 featuring Lunit SCOPE include: "Identification of HER2 ultra-low based on an artificial intelligence (AI)-powered HER2 subcellular quantification from HER2 immunohistochemistry images" (1115, Poster Board #93) "Deep learning–based chest CT model to predict treatment response to immune checkpoint inhibitors in non-small cell lung cancer independently and additively to histopathological biomarkers" (8536, Poster Board #400) "Artificial intelligence (AI) –powered H&E whole-slide image (WSI) analysis to predict recurrence in hormone receptor positive (HR+) early breast cancer (EBC)" (571, Poster Board #163) "Immune phenotype profiling based on anatomic origin of melanoma and impact on clinical outcomes of immune checkpoint inhibitor treatment" (9569, Poster Board #353) "Artificial intelligence (AI) -powered H&E whole-slide image (WSI) analysis of tertiary lymphoid structure (TLS) to predict response to immunotherapy in non-small cell lung cancer (NSCLC)" (3135, Poster Board #280) "Updated safety, efficacy, pharmacokinetics, and biomarkers from the phase 1 study of IMC-002, a novel anti-CD47 monoclonal antibody, in patients with advanced solid tumors" (2642, Poster Board #121) "Relationship between immune phenotype and treatment selection of Chemo-IO vs. IO-only in TPS-high NSCLC using hypothetical test-and-control group generation based on survival data extracted from phase III trials" (e13569) About Lunit Founded in 2013, Lunit is a medical AI company on a mission to conquer cancer. We harness AI-powered medical image analytics and AI biomarkers to ensure accurate diagnosis and optimal treatment for each cancer patient. Our FDA-cleared Lunit INSIGHT suite for cancer screening serves over 3,000 hospitals and medical institutions across 40+ countries. Our clinical findings are featured in top journals, including the Journal of Clinical Oncology and the Lancet Digital Health, and presented at global conferences such as the ASCO and RSNA. In 2024, Lunit acquired Volpara Health Technologies, setting the stage for unparalleled synergy and accuracy, particularly in breast health and screening technologies. Headquartered in Seoul, South Korea, with a global network of offices, Lunit leads in medical AI innovation. Discover more at lunit.io. SOURCE Lunit

ImmunotherapyASCOAcquisitionClinical ResultPhase 1

23 Feb 2024

·www.prnewswire.com

Immunofoco Announces the Dual Approval of IND Applications by the U.S. FDA and China CDE for the First EpCAM CAR-T Targeted at Advanced Solid Tumors

- The first EpCAM targeted CAR-T product obtained US/CN IND approval. - Acceptable safety profiles and preliminary efficacy were observed in Investigator-Initiated Trial (IIT) clinical studies of IMC001. SHANGHAI, Feb. 22, 2024 /PRNewswire/ -- Immunofoco, a company dedicated to developing cell therapy products for solid tumors, announced a significant milestone, that following the approval by the CDE in China for the clinical trial application of IMC001, an EpCAM-targeting autologous CAR-T cell product for infusion, it also received the IND approval from the U.S. FDA, for the treatment of EpCAM-positive advanced gastrointestinal tumors, including but not limited to advanced gastric cancer (GC) and gastroesophageal junction adenocarcinoma (GEJ). EpCAM serves as a biomarker for circulating tumor cells (CTCs), which is highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while its expression in normal tissues is low. It has been identified as a promising therapeutic target for GI tumors with a wide range of expandable indications. IMC001, through targeting EpCAM, is the first CAR-T product utilizing the strategy of "curing the solid tumors by treating them as hematologic malignancies ". In August 2023, the product was granted Orphan Drug Designation (ODD) by the U.S. FDA. The impressive clinical results of IMC001 have been shared at prestigious medical conferences, including being orally presented at the annual meeting of the European Society of Medical Oncology (ESMO) in 2022 and updated during the American Society of Clinical Oncology (ASCO) in 2023. As of January 31, 2024, in the IIT clinical trial for advanced gastric cancer, a safe and effective recommended dose has been identified, with two (2) out of five (5) patients in this dose group achieved partial remission (PR), with an overall response rate (ORR) of 40%. Among them, one PR patient underwent a successful radical surgery for gastric cancer 30 weeks after a single infusion of IMC001 and is still alive 85 weeks after IMC001 treatment. Another PR patient exhibited a 48% reduction in tumor size by week 16. Dr. Crystal Sun, Founder, Chairman, and CEO of Immunofoco, expressed her congratulations and gratitude to the entire team. She highlighted the significance of Immunofoco's achievement: securing dual IND approval for a second CAR-T product targeted for solid tumors in both the U.S. and China. Targeting EpCAM shows great potential for CAR-T treatment of solid tumors as it is highly expressed in primary, metastatic and circulating tumor cells. About 90% of the patients with gastrointestinal tumors exhibit EpCAM expression, which satisfies a broader clinical need. With the US/CN approval of this IND application, IMC001 is now poised to undertake further clinical trials and forge international collaborations, positioning itself as a promising new therapeutic option for patients with advanced GI tumors on a global scale. About Immunofoco Immunofoco has pioneered a clinical strategy focused on "curing the solid tumors by treating them as hematologic malignancies", addressing the challenges in solid tumor treatment, and the clinical advantages of treating hematologic malignancies. To improve the safety of CAR-T products, counteract tumor heterogeneity, and to enhance their effectiveness in tumor amplification and infiltration, we have developed innovative platforms such as Peri Cruiser®, SNR, and T-Booster. Driven by the clinical outcomes, our company maintains an extensive spectrum of product pipeline. Notably, our IMC002 (CLDN18.2 CAR-T) product obtained ODD from the U.S. FDA in July 2022, and its IND application has been approved in both the U.S. and China in April 2023. Similarly, our IMC001 (EpCAM CAR-T) product obtained ODD from the U.S. FDA in August 2023, with its IND application has been approved in both the U.S. and China in February 2024. The IMC008 (SNR CAR-T) product has rapidly moved to the IIT stage and received two ODD approval from the U.S. FDA in August 2023, for the treatment of gastric cancer and pancreatic cancer, respectively. Embodying the ethos of "collaboration, aspiration, and dedication for the best clinical results," our company brings together industry talents and experts to develop innovative cell therapies that offer enduring survival benefits for patients with solid tumors. For further details about Immunofoco, please visit our website at . SOURCE Immunofoco

ImmunotherapyINDCell TherapyClinical StudyASCO

100 Deals associated with Amulirafusp alfa

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Systemic Lupus Erythematosus	Phase 2	China	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	12 Aug 2024
CD20 positive Diffuse Large B-Cell Lymphoma	Phase 2	China	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	07 Jun 2023
Follicular Lymphoma	Phase 2	China	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	07 Jun 2023
Mantle-Cell Lymphoma	Phase 2	China	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	07 Jun 2023
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 2	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	01 May 2023
Diffuse Large B-Cell Lymphoma	Phase 2	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	01 May 2023
Indolent B-Cell Non-Hodgkin Lymphoma	Phase 2	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	01 May 2023
Refractory Marginal Zone Lymphoma	Phase 2	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	01 May 2023
Waldenstrom Macroglobulinemia	Phase 2	-	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	01 May 2023
CD20 Positive B-Cell Non-Hodgkin Lymphoma	Phase 2	China	ImmuneOnco Biopharmaceuticals (Shanghai), Inc.	02 Mar 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06535412 (NEWS)	Phase 1/2	Systemic Lupus Erythematosus	-	阿沐瑞芙普a	hfxfuzvxzc(eincxgvvll) = 初步数据显示，IMM0306在不同剂量组中均展现出良好的疗效和安全性，预示该药物分子在自免疾病治疗中的巨大潜力。 nitkadhgww (bmiylzjdro )	Positive	05 Aug 2025
NCT05771883 (Phase II, ASCO2025)	Phase 2	CD20 positive Follicular Lymphoma CD20-positive	34	Amulirafusp alfa 1.6 mg/kg + Lenalidomide 20 mg	xsydeorzps(mbwkxnyaev) = mjufmgzozi jnykuwjcys (vddilqdvhs ) View more	Positive	30 May 2025
NCT05805943 (Phase 1/2 study, Pubmed \| J Hematol Oncol)	Phase 1/2	B-cell lymphoma refractory CD20 +	48	Amulirafusp alfa	rhkwsapxli(udiflbarga) = nrpkvsjgca qwhleoparh (aovflosmht ) View more	Positive	18 Dec 2024
ASH2024	Not Applicable	CD20 Positive B-Cell Non-Hodgkin Lymphoma	-	IMM0306 1.6 mg/kg + Lenalidomide 20 mg	ihxjitldmr(vzjzkvduga) = 63.6% epmypziolm (koblvetmrj ) View more	-	08 Dec 2024
NCT05805943 (ASH2024) Manual	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma	48	IMM0306	radtdcgofp(tyzssmtsmd) = vrwjjaqdkv xxkvlxxrvk (dcvpoxpwoe ) View more	Positive	07 Dec 2024
NCT05805943 (ASH2024) Manual	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma	48	IMM0306 (r/r follicular lymphoma (FL))	radtdcgofp(tyzssmtsmd) = ffocvpmaqc xxkvlxxrvk (dcvpoxpwoe ) View more	Positive	07 Dec 2024
NCT05771883 (NEWS) Manual	Phase 1/2	Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma	27	阿沐瑞芙普α + 来那度胺 (R/R滤泡性淋巴瘤（FL）)	stmeukxhcm(zddahnptuo) = wyitakeyft yjuflmtelr (milfdrcqzx ) View more	Positive	06 Dec 2024
NCT05771883 (NEWS) Manual	Phase 1/2	Follicular Lymphoma \| Marginal Zone B-Cell Lymphoma	27	阿沐瑞芙普α + 来那度胺 (R/R边缘区淋巴瘤（MZL）)	stmeukxhcm(zddahnptuo) = vrmsslfutb yjuflmtelr (milfdrcqzx )	Positive	06 Dec 2024
NCT05805943 (ESMO2024) Manual	Phase 2	CD20 Positive B-Cell Non-Hodgkin Lymphoma CD20 Positive	16	Amulirafusp alfa (IMM0306) 2.0 mg/kg	ccsqtloavy(helytgbzfu) = soqdacwiqs fjfvxtpazb (kdvnhijbgi ) View more	Positive	15 Sep 2024
NCT05771883 (ESMO2024) Manual	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma CD20-positive	11	Amulirafusp alfa lenalidomide6 mg/kg	pyvfavkdai(cmmuciiedg) = Two DLTs (grade 4 PLT decreased without bleeding) were observed at 2.0 mg/kg IMM0306 + 20 mg Lenalidomide dose level. rwxsveruhr (bxnhehsqiq ) View more	Positive	15 Sep 2024
NCT05805943 (phase I study of IMM0306, ASCO2024)	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma	48	IMM0306 0.04 mg/kg	uqirazxczy(zxstmwulcz) = okoxwnxbbw smzsmogamb (vgayytznkt ) View more	Positive	24 May 2024
NCT05805943 (phase I study of IMM0306, ASCO2024)	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma	48	IMM0306 0.1 mg/kg	uqirazxczy(zxstmwulcz) = bwaozmoart smzsmogamb (vgayytznkt ) View more	Positive	24 May 2024
NCT05771883 (Phase I, ASCO2024)	Phase 1	CD20 Positive B-Cell Non-Hodgkin Lymphoma CD20-positive	8	IMM0306 1.6 mg/kg + Lenalidomide 20 mg	lubyabfvkb(genxyrpfof) = One pt experienced treatment related serious adverse event ykkfsfjxjz (redrpgtbju )	Positive	24 May 2024

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